510(k) Report

Devices descending from K023113

689 later devices reach Replace Tiunite Endosseous Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+5K220978TSX ImplantsBiomet 3i, LLC20221—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+5K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190552JJ Implant SystemJj Implants20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K160244VARIOuniteThommen Medical AG201615—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+5K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K133050One Plus Implant SystemOsseofuse, Inc.20141—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133991ISYAltatec GmbH20142—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+5K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—